Vallon Pharmaceuticals Announces Issuance of New European Patent Covering Method of Use and Composition of Matter for ADAIR
-Patent bolsters intellectual property protection as Company’s partner, MEDICE, works to develop and potentially commercialize ADAIR in Europe and the UK
PHILADELPHIA, PA, July 13, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today announced that the European Patent Office has issued patent number EP3576719B1 covering ADAIR1, the Company’s proprietary abuse-deterrent formulation of immediate-release dextroamphetamine.
ADAIR is being developed for Europe and the UK through a license and collaboration agreement with MEDICE Arzneimittel Pütter GmbH, a leader in the European ADHD market. Under the terms of the agreement, Vallon will receive development and sales milestone payments and double-digit sales-based royalty payments. The issuance of this Composition of Matter and Method of Use patent provides additional protection as MEDICE works towards the potential commercialization of ADAIR in the European Union and United Kingdom. In the US, the Company continues to develop ADAIR, leveraging the 505(b)(2) regulatory pathway. The Company is currently conducting a pivotal intranasal abuse study, the SEAL Study, in recreational drug abusers.
David Baker, President & Chief Executive Officer of Vallon commented, “There is a clear and growing unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse. We continue to be encouraged by the potential of our novel platform technology, which we believe can also be applied to other prescription drugs that have abuse potential. We are pleased to successfully expand our intellectual property portfolio with the issuance of this new European patent.”
The new European patent covers composition of matter and method of use for ADAIR, with a base patent term extending until 2038. The design and development of an abuse-deterrent formulation involves the balance of limiting the potential for manipulation and abuse while maintaining acceptable dissolution rates and bioavailability. ADAIR was previously granted two patents in the United States with a base patent term extending until 2037, excluding patent term extensions.
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Dextroamphetamine has been used clinically for more than 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the FDA.
About Vallon Pharmaceuticals Inc.
Vallon Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The Company is focused on the development of new medications to help patients with central nervous system (CNS) disorders. The Company’s lead investigational product candidate, ADAIR, is a novel abuse deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.
References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.
Forward Looking Statements
This press release contains “forward-looking statements” that are based on Vallon’s current expectations and subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation, Vallon’s ability to execute its business plan, continue its growth and fund its ongoing business activities as planned, Vallon’s ability to develop and commercialize its product candidates, expectations related to results of clinical trials and studies, Vallon’s expectations with respect to the important advantages it believes its abuse-deterrent formulation of drugs have over similar drugs in the market and the growing need for abuse-deterrent formulations of drugs, Vallon’s ability to utilize the 505(b)(2) regulatory pathway, Vallon’s ability to obtain FDA approval of ADAIR and its other product candidates, and Vallon’s expectations with respect to its cash runway. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Vallon’s Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
JTC Team, LLC
1 ADAIR is not approved by the FDA